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Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study
Prospective, international, multicenter, single-arm, post-market study. OBJECTIVE. The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we pre...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8912964/ https://www.ncbi.nlm.nih.gov/pubmed/34812195 http://dx.doi.org/10.1097/BRS.0000000000004283 |
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author | Deer, Timothy R. Falowski, Steven M. Moore, Gregory A. Hutcheson, J. Kelby Peña, Isaac Candido, Kenneth Cornidez, Eric G. zu Fraunberg, von und Blomme, Bram Capobianco, Robyn A. |
author_facet | Deer, Timothy R. Falowski, Steven M. Moore, Gregory A. Hutcheson, J. Kelby Peña, Isaac Candido, Kenneth Cornidez, Eric G. zu Fraunberg, von und Blomme, Bram Capobianco, Robyn A. |
author_sort | Deer, Timothy R. |
collection | PubMed |
description | Prospective, international, multicenter, single-arm, post-market study. OBJECTIVE. The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261). SUMMARY OF BACKGROUND DATA. Passive recharge burst spinal cord stimulation (B-SCS) uniquely mimics neuronal burst firing patterns in the nervous system and has been shown to modulate the affective and attentional components of pain processing. METHODS. After a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months. RESULTS. Significant improvements in physical, mental, and emotional functioning observed after 6 months of treatment were maintained at 2 years. Pain catastrophizing scale (PCS) scores dropped below the population norm. Health-related quality of life on EQ-5D improved across all domains and the mean index score was within one standard deviation of norm. Pain reduction (on NRS) was statistically significant (P < 0.001) at all timepoints. Patient reported pain relief, a stated percentage of improvement in pain, was consistent at all timepoints at 60%. Patients reported significant improvements across all measures including activity levels and impact of pain on daily life. At 24 months, 84% of subjects were satisfied and 90% would recommend the procedure. Subjects decreased their chronic pain medication intake for all categories; 38% reduced psychotropic and muscle relaxants, 46% reduced analgesic, anti-convulsant and NSAIDs, and 48% reduced opioid medication. Adverse events occurred at low rates without unanticipated events. CONCLUSION. Early positive results with B-SCS were maintained long term. Evidence across multiple assessment tools show that B-SCS can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life. Level of Evidence: 3 |
format | Online Article Text |
id | pubmed-8912964 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-89129642022-03-18 Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study Deer, Timothy R. Falowski, Steven M. Moore, Gregory A. Hutcheson, J. Kelby Peña, Isaac Candido, Kenneth Cornidez, Eric G. zu Fraunberg, von und Blomme, Bram Capobianco, Robyn A. Spine (Phila Pa 1976) Clinical Case Series Prospective, international, multicenter, single-arm, post-market study. OBJECTIVE. The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261). SUMMARY OF BACKGROUND DATA. Passive recharge burst spinal cord stimulation (B-SCS) uniquely mimics neuronal burst firing patterns in the nervous system and has been shown to modulate the affective and attentional components of pain processing. METHODS. After a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months. RESULTS. Significant improvements in physical, mental, and emotional functioning observed after 6 months of treatment were maintained at 2 years. Pain catastrophizing scale (PCS) scores dropped below the population norm. Health-related quality of life on EQ-5D improved across all domains and the mean index score was within one standard deviation of norm. Pain reduction (on NRS) was statistically significant (P < 0.001) at all timepoints. Patient reported pain relief, a stated percentage of improvement in pain, was consistent at all timepoints at 60%. Patients reported significant improvements across all measures including activity levels and impact of pain on daily life. At 24 months, 84% of subjects were satisfied and 90% would recommend the procedure. Subjects decreased their chronic pain medication intake for all categories; 38% reduced psychotropic and muscle relaxants, 46% reduced analgesic, anti-convulsant and NSAIDs, and 48% reduced opioid medication. Adverse events occurred at low rates without unanticipated events. CONCLUSION. Early positive results with B-SCS were maintained long term. Evidence across multiple assessment tools show that B-SCS can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life. Level of Evidence: 3 Lippincott Williams & Wilkins 2022-04-01 2021-11-22 /pmc/articles/PMC8912964/ /pubmed/34812195 http://dx.doi.org/10.1097/BRS.0000000000004283 Text en Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
spellingShingle | Clinical Case Series Deer, Timothy R. Falowski, Steven M. Moore, Gregory A. Hutcheson, J. Kelby Peña, Isaac Candido, Kenneth Cornidez, Eric G. zu Fraunberg, von und Blomme, Bram Capobianco, Robyn A. Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study |
title | Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study |
title_full | Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study |
title_fullStr | Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study |
title_full_unstemmed | Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study |
title_short | Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study |
title_sort | passive recharge burst spinal cord stimulation provides sustainable improvements in pain and psychosocial function: 2-year results from the triumph study |
topic | Clinical Case Series |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8912964/ https://www.ncbi.nlm.nih.gov/pubmed/34812195 http://dx.doi.org/10.1097/BRS.0000000000004283 |
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